Efficacy of Streptococcus Salivarius BLIS (Bacteriocin-like Inhibitory Substance) K12 as Preventive Measure for Rheumatic Children.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- number of Strep throat infections while in study
研究概览
简要总结
The purpose of this study is to determine whether daily treatment with Streptococcus Salivarius BLIS K-12 prevents streptococcal throat infection in children that have had an episode of rheumatic fever.
详细描述
Children diagnosed with Rheumatic fever are currently given preventive streptococcal treatment with either monthly IM (intramuscular injection) Penicillin or daily oral Penicillin.
This preventive treatment is recommended for years until the child is 20 y old or even later. The compliance rate for this treatment declines significantly with time (the injections are painful) and even with good adherence the prevention is not complete.
In the last few years a new product licensed as "BLIS K-12" has been developed and approved by FDA as GRAS (generally recognized as safe) status from 2011.
This probiotic treatment prevents the pathogenic Strep A from adhering to the throat of the child thus preventing the infection. This kind of prevention is better for the long run for the patient and for the surrounding, It is better tolerated, is effective even if a dose is skipped or missed is not painful and is tasty to the children.
So the investigators assumption is that giving this product to children instead of Penicillin either orally or intramuscularlly will be better tolerated thus give a better protection profile with much less side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatic heart disease with recommended strep prophylaxis
排除标准
- •less than one year from first diagnosis
- •refusal to take the tablets
结局指标
主要结局
number of Strep throat infections while in study
时间窗: six month
次要结局
未报告次要终点
研究者
Dr Yael Garty MD
MD
Kaplan Medical Center
